Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump

NCT ID: NCT06207838

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-14
• Study Completion Date: 2024-12-31

Brief Summary

Older people with diabetes have a higher risk for cognitive impairment and for physical disability whether this may be effected by an improvement in glucose indices is unknown. Thus, the aim of this study is to assess the efficacy of AHCL in people with type 1 diabetes in improving glucose indices, quality of life and physical capacity indices

Detailed Description

Recent advances in insulin pumps, continuous glucose monitoring (CGM) devices, and control algorithms have resulted in an acceleration of progress in the development of the automated systems of insulin delivery including advanced hybrid closed loop (HCL) insulin pumps. The results of the AHCL insulin pump based studies published so far are very encouraging, including that Medtronic-sponsored study performed at our center "Transition of CSII/CGM naïve patients directly into AHCL (780G) insulin pump: the impact on glucose patterns and quality of life measures" (1-6). Unfortunately there is little data concerning the usage of AHCL systems in older patients. The management of these individuals is particularly challenging as older adults with type 1 diabetes are especially vulnerable to hypoglycaemia. The recent ADA/EASD consensus underlines that the use of advanced technologies in older individuals is useful and should not be discontinued or a priori excluded because of the older age (7). Since the AHCL systems are very effective in hypoglycemia prevention they could be considered the treatment of choice in older patients with T1DM. The open question is how effectively would older individuals adopt this advanced technology, how would they accept it, and if the simplicity in terms of everyday usage of AHCL versus less advanced technologies would be appreciated by older individuals with T1DM. Older people with diabetes have a higher risk for cognitive impairment and for physical disability whether this may be effected by an improvement in glucose indices is unknown. Thus, the aim of this study is to assess the efficacy of AHCL in people with type 1 diabetes in improving glucose indices, quality of life and physical capacity indices

Conditions

Diabetes Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Actual therapy

The patient continues Multiple Daily Injection/Insulin Pump Therapy with or without CGM use as per routine procedures

Group Type: NO_INTERVENTION

No interventions assigned to this group

Advanced Hybrid Cloosed Loop System

The patients will be switched to MiniMed 780G advanced hybrid cloosed loop system/ AHCL system

Group Type: EXPERIMENTAL

MiniMed 780G system

Intervention Type: DEVICE

The MiniMed™ 780G system automatically adjust insulin delivery to patient needs for an easier way to stabilise glucose levels. It features an advance level of automation for diabetes management, known as SmartGuard™ technology. If patient glucose levels are trending high, it gives patient more insulin. Technology is CE marked.

Interventions

MiniMed 780G system

The MiniMed™ 780G system automatically adjust insulin delivery to patient needs for an easier way to stabilise glucose levels. It features an advance level of automation for diabetes management, known as SmartGuard™ technology. If patient glucose levels are trending high, it gives patient more insulin. Technology is CE marked.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age over 65 years

2. T1DM

3. Willing to participate in a study for the specified duration

4. Willing to perform ≥ 4 finger stick blood glucose measurements daily

5. Willing to wear the system continuously throughout the study

6. Glycosylated hemoglobin (A1C) value less than 10.0% at time of screening visit

7. Treated with MDI/CSII (with exclusion of 780G)

8. Willing to perform at least 4 BGM/day, when on MDI/CSII

9. Lack of advanced complications of diabetes, eGFR>30

Exclusion Criteria

1. Severe concurrent illness

2. Laboratory abnormalities, or medications that might affect study participation,

3. Severe renal impairment (eGFR<30)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Tomasz Klupa

Prof. Tomasz Klupa

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomasz Klupa, Prof.

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Locations

Hospital University; Jagiellonian University Medical College

Krakow, , Poland

Countries

Poland

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

1072.61201.5.2023

Identifier Type: -

Identifier Source: org_study_id